Leone SPA

Australian Wire Super Hard Heat-Trtd 18.

Registry build 21.09.26
43manufacturers in China registered for this device type
621catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (15), Guangdong (9), Jiangsu (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZC
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Yancheng Denrum Medical Apparatus Co., Ltd. Yancheng Jiangsu Contract manufacturer 5
Heilongjiang Rainbow Technology Co., Ltd. Jiamusi Heilongjiang Contract manufacturer 2
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25

Showing 12 of 43. All 43 manufacturers in China registered for Wire, Orthodontic

Record

Regulatory record for Leone SPA
Listed by Leone SPA, Italy
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-06-25
Record revised 2021-03-15 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Leone SPA
Catalogue number Size Status
C6340-916 In distribution
C7150-918 In distribution
C0400-08 In distribution
C5912V16 In distribution
C6912-16 In distribution
C6142V17 In distribution
C5972-916 In distribution
C8180-18 In distribution
C3210-18 In distribution
K4610-36 In distribution
C8017-17 In distribution
C5915-019 In distribution
C5969-17 In distribution
C5155-18 In distribution
C6445-19 In distribution
K4051-25 In distribution
C0420-12 In distribution
C3951V13 In distribution
C8080-16 In distribution
C0420-16 In distribution
C3012-19 In distribution
C3150-16 In distribution
C5959-12 In distribution
C3150-14 In distribution
C7900-36 In distribution
C6342V917 In distribution
C5954-16 In distribution
C5915-918 In distribution
C7150-916 In distribution
C0451-07 In distribution
C5918-14 In distribution
C8080-14 In distribution
C5911-918 In distribution
C6242-916 In distribution
C5911-018 In distribution
C6042-16 In distribution
C2050-16 In distribution
C4970-16 In distribution
C5110-12 In distribution
C0401-09 In distribution
C5110-16 In distribution
C5915V918 In distribution
C5914-918 In distribution
C5952-016 In distribution
C8080-40 In distribution
C0401-10 In distribution
C6342-16 In distribution
C0400-14 In distribution
C6141-916 In distribution
C5950-920 In distribution
C7112-16 In distribution
C5954-919 In distribution
C6952-16 In distribution
C5982-916 In distribution
C8380-14 In distribution
C3050-18 In distribution
C6342V16 In distribution
C6345V919 In distribution
C0420-20 In distribution
K4050-28 In distribution
C5914-16 In distribution
C5155-19 In distribution
C5952V16 In distribution
C5975-918 In distribution
C6910-916 In distribution
C6340-914 In distribution
C3252-18 In distribution
C5950V918 In distribution
C6240-14 In distribution
C5929-16 In distribution
C0400-09 In distribution
C5910V912 In distribution
C6950-18 In distribution
C5914-18 In distribution
C3912V17 In distribution
C6240-18 In distribution
C8128-21 In distribution
C6145V19 In distribution
C6912-916 In distribution
C8580-15 In distribution
C6441-16 In distribution
C3952V18 In distribution
C5955-18 In distribution
C3111-16 In distribution
C5541-16 In distribution
C3150-20 In distribution
C8022-18 In distribution
C5152-16 In distribution
C6140-918 In distribution
C3152-18 In distribution
C6442-16 In distribution
C5915-021 In distribution
C3012-18 In distribution
C6040-14 In distribution
C0400-07 In distribution
C5150-18 In distribution
C6140-18 In distribution
C7115-21 In distribution
C2050-20 In distribution
C6142-17 In distribution
C8025-20 In distribution
C5912-16 In distribution
C6440-16 In distribution
C6045V919 In distribution
C3152-26 In distribution
C5985-19 In distribution
C6241-916 In distribution
C8180-16 In distribution
C6142V917 In distribution
C5915-919 In distribution
C5955-19 In distribution
C6341-16 In distribution
C5957-918 In distribution
C3112-18 In distribution
C8080-18 In distribution
C5956-916 In distribution
C6442-916 In distribution
C5917-18 In distribution
C5950V916 In distribution
C5950-018 In distribution
C6342V17 In distribution
C6145-919 In distribution
C7150-24 In distribution
C5910-14 In distribution
C6442-917 In distribution
C6045V19 In distribution
C6240V18 In distribution
C5971-16 In distribution
C8380-20 In distribution
C5910-012 In distribution
C2010-16 In distribution
C5950-20 In distribution
C8422-16 In distribution
C5951-016 In distribution
C6440-914 In distribution
C5955-017 In distribution
C8025-21 In distribution
C6045-919 In distribution
C6040-914 In distribution
C5935-18 In distribution
C5911-18 In distribution
C5912-016 In distribution
C7922-16 In distribution
C5958-20 In distribution
C5155-21 In distribution
C0450-13 In distribution
C5970-916 In distribution
C7112-921 In distribution
C5932-916 In distribution
C6245-19 In distribution
C7110-916 In distribution
C0450-10 In distribution
C7115-16 In distribution
C5992-916 In distribution
C5910-920 In distribution
C6042-917 In distribution
C6341V16 In distribution
C6952-19 In distribution
C5910V16 In distribution
C3252-16 In distribution
K4051-30 In distribution
C5931-916 In distribution
C5958-920 In distribution
C6242-917 In distribution
C5953-914 In distribution
C5914-916 In distribution
C3212-19 In distribution
C6440-18 In distribution
C5917-919 In distribution
C5915-21 In distribution
C8922-16 In distribution
C5917-918 In distribution
C5954-916 In distribution
C4152-19 In distribution
C5440-19 In distribution
C5930-16 In distribution
C6442-17 In distribution
C5916-14 In distribution
C5150-12 In distribution
C3112-36 In distribution
C6442V16 In distribution
C5115-17 In distribution
C0430-18 In distribution
C6242V917 In distribution
C7151-24 In distribution
K4280-30 In distribution
F6100-02 In distribution
C5540-17 In distribution
C6340V914 In distribution
C7115-916 In distribution
C6340V14 In distribution
C6910-16 In distribution
C3212-16 In distribution
C5953-14 In distribution
C5916-916 In distribution
C5110-20 In distribution
C6912-19 In distribution
C6952-917 In distribution
C5115-21 In distribution
C5953-916 In distribution
C4950-14 In distribution
C5975-21 In distribution
C8380-18 In distribution
C8016-16 In distribution
C3951V14 In distribution
C3052-19 In distribution
C7015-921 In distribution
C5913-916 In distribution
C8025-18 In distribution
C0450-14 In distribution
C0451-10 In distribution
C5954-18 In distribution
C6952-17 In distribution
C6912-919 In distribution
C5950-12 In distribution
C5975-19 In distribution
C8580-17 In distribution
C3110-18 In distribution
C3110-16 In distribution
C5540-21 In distribution
C5915-921 In distribution
K4050-23 In distribution
C0450-11 In distribution
C5910-918 In distribution
C5951V916 In distribution
C3952V16 In distribution
C5951-18 In distribution
C6440-916 In distribution
C8880-19 In distribution
C7115-917 In distribution
C5951-16 In distribution
C5931-16 In distribution
C6950-916 In distribution
C5957-17 In distribution
C8080-45 In distribution
C5910-914 In distribution
C5150-16 In distribution
C5954-917 In distribution
C5545-17 In distribution
K4051-28 In distribution
C5912V917 In distribution
C5935-21 In distribution
C7110-18 In distribution
C5745-17 In distribution
C3250-18 In distribution
C8225-17 In distribution
C5955V918 In distribution
C5950-914 In distribution
C5112-16 In distribution
C5955V917 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Wire, Orthodontic G & H Wire Company 2,746
Europa G & H Wire Company 2,409
Pg Supply PG Supply, Inc. 1,990
Trueform G & H Wire Company 1,984
G4 Nickel Titanium G & H Wire Company 957
Tanzo American Orthodontics 906
Aditek Aditek DO Brasil S/A 879
G4 Europa Nickel Titanium G & H Wire Company 819
3M™ Unitek™ 3M Unitek 729
Orthodontic wire Dentos, Incorporated 711
Orthoquest Young Innovations Inc. 698
NT3 American Orthodontics 694

Showing 12 of 679. All products under Wire, Orthodontic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer